Safety and Pharmacokinetics of Recombinant Anti-EGFr Antibody in Patients With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title: A PhaseⅠ,Open-label, Single-center Study to Evaluate Safety and Pharmacokinetics of Recombinant Anti-Epidermal Growth Factor Receptor (EGFr) Antibody in Patients With Metastatic Colorectal Cancer

Status Recruiting

Clinical Trial Summary

A single-central,open-label,safety,pharmacokinetics,phase I study. Biological:Recombinant Anti-EGFr Antibody Two dose levels: Low-dose level patients received initial dose 100 mg/m2 and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.High-dose level patients received cetuximab initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.

Clinical Trial Description

Two dose levels were tested: Recombinant Anti-EGFr Antibody Low-dose level patients received initial dose 100 mg/m2 and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.High-dose level patients received cetuximab initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent. Dose limiting toxicity (DLT) was defined as: grade 4 or 3-time grade 3 cutaneous toxicity,successive 3-time infusion suspension due to grade 3 cutaneous toxicity,any other ≥grade 3 adverse reaction or acute pneumonia, interstitial pneumonia, and other lung diseases.

Cohorts of 3 patients receive single dose of low-dose group of Recombinant Anti-EGFr Antibody. If the ratio of the dose limiting toxicity (DLT) after a single dose is not more than a third, then high-dose group can be treated.After high-dose(initial dose 400 mg/m2, iv., 2 h),safety will be observed and blood sampling will be taken for a single dose pharmacokinetic analysis.After 4-week continuous administration (loading dose 400 mg/m2, iv., 2 h; maintenance dose 250 mg/m2, iv, 1 h, q1w) until disease progression, unacceptable toxicity reaction, death or revocation of informed consent.As the blood concentration reach steady state, blood sampling will be collected for steady-state pharmacokinetic analysis, for 1 week.After completion of the steady-state pharmacokinetics,patients can receive chemotherapy,and safety (including immunogenicity) and curative effect will be observed. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT03017807
• Study type: Interventional
• Source: Sichuan Kelun Pharmaceutical Co., Ltd.
• Contact: Zhou Jianglin
• Phone: 86-028-67252675
• Email: zhoujl@kelun.com
• Status: Recruiting
• Phase: Phase 1
• Start date: December 2016
• Completion date: October 2017